Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Paraffins (petroleum), normal C>10 is not expected to be developmental and reproductive toxicant based on the results (NOAEL higher than 1000 mg/kg/day and a lack of systemic toxicity) obtained through the studies on Decane and Undecane (substances in the category "Hydrocarbons, C9 -C14, aliphatics, <2% aromatics".

See also testing proposal.


Short description of key information:
Two studies for the reproduction toxicity are available on decane and undecane showing respectively a NOAEL >1000 mg/kg/day for the reproductive performance and a NOAEL>1000 mg/kg/day for both developmental toxicity and reproductive toxicity.
See also testing proposal.

Effects on developmental toxicity

Description of key information
Two developmental studies are available on C9-C12, n-alkanes, isoalkanes, cyclics, <2% aromatics and C16-C20 n-alkanes, isoalkanes, cyclics, <2% aromatics showing respectively a NOAEL >1000 mg/kg/day for developmental toxicity and a NOAEL>1000 mg/kg/day for both maternal and developmental toxicity.
Additional information

Two developmental studies are available on C9-C12, n-alkanes, isoalkanes, cyclics, <2% aromatics and C16 -C20 n-alkanes, isoalkanes, cyclics, <2% aromatics showing a NOAEL higher than 1000 mg/kg/day for maternal and developmental toxicity. Based on these results, Paraffins (petroleum), normal C>10 is also expected not to cause developmental and maternal toxicity.

Justification for classification or non-classification

These findings do not warrant the classification of C10 -C17, n-alkanes, <2% aromatic hydrocarbons as a reproductive or developmental toxin under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/548/EEC for dangerous substances.